An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma
Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
Trial Information
An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma
Inclusion Criteria:
- Adult patients 18-75 years of age
- Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma
- >/=1 measurable lesion
- No prior treatment (no corticosteroids or radiotherapy)
Exclusion Criteria:
- Transformed follicular lymphoma
- Cerebral or meningeal lymphomaotus localization
- Uncontrolled concurrent infection
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall objective complete response rate
Outcome Time Frame:
Day 50
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
M39006
NCT ID:
NCT01392716
Start Date:
October 1997
Completion Date:
February 2006
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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